Following a recommendation from the international steering committee, the World Health Organisation (WHO) has pulled the steroid drug hydroxychloroquine and HIV treatment combination lopinavir/ritonavir from their ongoing “COVID Solidarity” trials. Established by the WHO, the Solidarity Trial is trying to find a working treatment of hospitalised patients.
The WHO said in a press release that the committee’s recommendation follows mounting evidence comparing hydroxychloroquine and lopinavir/ritonavir with standard-of-care treatment from the trial’s interim results. At the WHO Summit on COVID-19 research and innovation held on 1-2 July, the evidence from all trials was reviewed and summarised, the release said.
When compared, the WHO found that hydroxychloroquine and lopinavir/ritonavir “produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care”.
The agency said that while there was no “solid evidence” of increased mortality for hospitalised patients who had been administered the drugs, there were “some associated safety signals in the clinical laboratory findings” of an associated trial.
WHO says the decision won’t affect possible trials on patients who aren’t hospitalised, or on those receiving the drugs before potential exposure to the coronavirus or shortly afterwards.
However, the agency compiled some safety information based on clinical findings in the associated Discovery Trial, an arm of the Solidarity Trial. WHO said it would report the findings in an upcoming peer-reviewed publication. The agency is readying interim Solidarity results for peer-reviewed publication.
The decision applies only to WHO’s Solidarity Trial in hospitalised patients. It does not rule out its use in other studies to treat non-hospitalised patients. It does not discard the drug’s use as a pre- or post-exposure preventive treatment for COVID-19 either, the WHO said.
In laboratory experiments earlier this year, doctors and scientists had observed that hydroxychloroquine was capable of blocking the SARS-CoV-2 virus that causes COVID-19, but this effect did not replicate in rigorous trials on people.